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DewDiligence

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Re: zipjet post# 114385

Wednesday, 02/09/2011 7:45:49 AM

Wednesday, February 09, 2011 7:45:49 AM

Post# of 257253
The section of the FDA Copaxone label that specifies the average molecular weight has changed at least once since Copaxone was initially approved.

The current label, effective 2/27/09, specifies a molecular-weight range of 5-9 kDa:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020622s057lbl.pdf (see page 9 of label on page 11 of pdf file).

The prior label, effective 7/12/01, specifies a molecular-weight range of 4.7-11 kDa:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20622s15lbl.pdf (see first page of pdf file).

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